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Randomized Phase III Study to Evaluate the Efficacy and Safety of Xyzal® (Levocetirizine) vs Zyrtec® (Cetirizine) in Subjects With Dermatitis and Eczema
This study has been completed.
First Received: September 12, 2006   Last Updated: March 13, 2009   History of Changes
Sponsored by: UCB
Information provided by: UCB
ClinicalTrials.gov Identifier: NCT00375713
  Purpose

Korean double-blind non-inferiority study to asses the efficacy (as measured by the responder rate of pruritus severity score by the patient at visit 4 or end-of-treatment visit over the 2 weeks treatment period) and safety of Xyzal® to Zyrtec® in subjects suffering from dermatitis and eczema with pruritus symptoms


Condition Intervention Phase
Dermatitis
Eczema
Drug: Levocetirizine
Drug: Cetirizine
Drug: Placebo Levocetirizine (P-ZRT)
Drug: Placebo Cetirizine (P-XYR)
Drug: Standard topical steroid ointment
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A Multi-Centre, Double-Blind, Double-Dummy, Randomized, Active-Controlled Phase III Study to Evaluate the Efficacy and Safety of Xyzal® 5mg od vs Zyrtec® 10mg od in Subjects Aged 15 Years and Above With Dermatitis and Eczema

Resource links provided by NLM:


Further study details as provided by UCB:

Primary Outcome Measures:
  • Responder status in Pruritus Severity Score (response = mild or none in severity score). [ Time Frame: Day 7 and 14 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change of mean Pruritus Severity Score [ Time Frame: Baseline, Day 7 and 14 ] [ Designated as safety issue: No ]
  • Duration of pruritus (stated in categories) [ Time Frame: Baseline, Day 7 and 14 ] [ Designated as safety issue: No ]
  • Global Improvement Rate (Exacerbation, No change, Mild improvement,Moderate improvement, Marked improvement) [ Time Frame: Baseline, Day 7 and 14 ] [ Designated as safety issue: No ]

Enrollment: 466
Study Start Date: October 2005
Study Completion Date: May 2006
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Levocetirizine: Experimental
Levocetirizine (LCTZ)
Drug: Levocetirizine
1 Levocetirizine 5mg tablet per day before bedtime for 14 days
Drug: Standard topical steroid ointment
1% hydrocortisone ointment, applied 2-3 times a day to all affected areas for 14 days
Cetirizine: Active Comparator
Cetirizine
Drug: Cetirizine
1 Cetirizine 10mg tablet per day before bedtime for 14 days.
Drug: Placebo Levocetirizine (P-ZRT)
1 P-ZRT tablet per day before bedtime for 14 days
Drug: Placebo Cetirizine (P-XYR)
1 P-XYR tablet per day before bedtime for 14 days.
Drug: Standard topical steroid ointment
1% hydrocortisone ointment, applied 2-3 times a day to all affected areas for 14 days

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects diagnosed as having atopic dermatitis, contact dermatitis, prurigo, pruritus in the dermatitis and eczema
  • Subjects who require and agree to the concomitant use of a topical steroid preparation.
  • Subjects having a minimum level of pruritus and having used topical hydrocortisone during the run -in period
  • Written informed consent signed and dated by subject/legal guardian
  • Female subjects with childbearing potential are eligible if they use a medically accepted contraceptive method and have a negative pregnancy test.

Exclusion Criteria:

  • Subjects with a known hypersensitivity to cetirizine or levocetirizine
  • Any clinically significant condition that might interfere with the treatment evaluation, both for efficacy and safety
  • Have used forbidden concomitant medications or having not respected adequate wash-out periods as defined by the protocol
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00375713

Locations
Korea, Republic of
Seoul, Korea, Republic of
Kyeonggi-Do, Korea, Republic of
Gyeunggi-do, Korea, Republic of
Sponsors and Collaborators
UCB
Investigators
Study Director: Kevin Beh, MD UCB
  More Information

No publications provided

Responsible Party: UCB ( Study Director )
Study ID Numbers: A00410
Study First Received: September 12, 2006
Last Updated: March 13, 2009
ClinicalTrials.gov Identifier: NCT00375713     History of Changes
Health Authority: Korea: Food and Drug Administration

Keywords provided by UCB:
Dermatitis
Eczema
Pruiritus
Xyzal
Zyrtec
Levocetirizine
Cetirizine

Study placed in the following topic categories:
Neurotransmitter Agents
Hydrocortisone
Skin Diseases
Cortisol succinate
Eczema
Anti-Allergic Agents
Cetirizine
Histamine
Histamine Antagonists
Levocetirizine
Skin Diseases, Eczematous
Histamine H1 Antagonists
Histamine phosphate
Hydrocortisone acetate
Dermatitis

Additional relevant MeSH terms:
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Skin Diseases
Physiological Effects of Drugs
Histamine Agents
Eczema
Anti-Allergic Agents
Cetirizine
Pharmacologic Actions
Histamine Antagonists
Levocetirizine
Therapeutic Uses
Skin Diseases, Eczematous
Histamine H1 Antagonists
Histamine H1 Antagonists, Non-Sedating
Dermatitis

ClinicalTrials.gov processed this record on July 02, 2009